Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration
Inclusion Criteria
Inclusion criteria:
Histologically documented evidence of melanoma
Stage III-IV melanoma according to the 2001 AJCC criteria
Radical lymph node dissection planned, either with curative (stage III) or palliative
(stage IV) intent
Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
HLA-A2.1 phenotype according to lymphocyte HLA typing
ECOG performance status 0-1, life expectancy > 3 months
Age 18-75 years
Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no
residual toxicity of prior treatment.
WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine <
150 μmol/l, serum bilirubin < 25 μmol/l
Written informed consent
Expected adequacy of follow-up
Exclusion criteria:
No clinical signs of CNS metastases, in patients with a clinical suspicion of other
metastases diagnostic tests should be performed to exclude this.
No concomitant use of corticosteroids or other immunosuppressive agents
No history of second malignancy within the last 5 years. Adequately treated basal
carcinoma of skin or carcinoma in situ of cervix is acceptable within this period
No serious concomitant disease, no active infections. No autoimmune disease or organ
allografts, no clinical suspicion of HIV or Hepatitis B
No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads,
cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to
shell fish (contains KLH)
No pregnant or lactating women